1. Field of the Invention
The present invention is in the field of clinical diagnostic services, i.e., in the industry of identification, characterization, quantification of biological agents associated with disease conditions. The present invention is particularly directed toward a method and materials for the collection and maintenance of detectability of a plurality of species of microbiological agents selected from the group consisting of bacteria, fungi, viruses, and protozoa in a single clinical sample and managing information associated with a plurality of samples for reporting a sum of diagnostic results for each sample.
2. Description of the Related Art
Clinical diagnostics provide an essential aid to the physician for the diagnosis and monitoring of numerous pathologies and infectious diseases. Rapid and accurate identification of causative agents of a myriad of different human pathophysiological conditions is a paramount requisite to effective treatment.
A biological sample generally is taken from the patient, most often at the request of a physician, and sent to a medical laboratory for analysis to establish or confirm a diagnosis of clinical symptoms. A physician may suspect a particular causative agent upon physical examination. However, certain symptoms may be characteristic of a plethora of different causative agents. Therefore, due to misdiagnoses of causative agents, patients may be treated non-efficaciously. Moreover, in other instances, a physician may request a certain diagnostic test to be performed on a clinical specimen wherein the test subsequently produces a negative result. Then, of course, further clinical samples and diagnostic testing are required. In many instances, due to the lack of timely and accurate diagnoses, patients' original conditions progress to the further detriment of treatability and to the well-being of the patient. Accurate clinical diagnosis is critical to specifically identify causative agents in a timely manner which mediates pathophysiological conditions. Accordingly, a need indeed exists for materials and a method, for example, to collect an accurate clinical sample, e.g. a “snapshot,” representative of vaginal flora, i.e., a certain gynecological microbiological environment, and maintain the detectability of a plurality of species in a single gynecological sample.
Diagnostic kits are available, for example, capable of detecting several specific species. However, in many instances current diagnostic products and services are inadequate to identify the causative agent or are inoperable under clinical circumstances.
Advances in the detection of C. trachomatis and N. gonorrhoeae, for example, have included the development of nucleic acid amplification tests from cervical as well as urine samples. The Roche COBAS AMPLICOR™ CT/NG Test, for example, is an in vitro multiplex diagnostic test that can detect either or both Chlamydia trachomatis or Neisseria gonorrhoeae in endocervical or urethral swabs and/or urine samples. The COBAS AMPLICOR™ Analyzer is an instrument which automates amplification and detection of the PCR process. The test utilizes polymerase chain reaction (PCR) nucleic acid amplification and nucleic acid hybridization (Roche Diagnostic Systems, Branchburg, N.J.). APTIMA COMBO 2 Assay is a Gen-Probe nucleic acid amplification test that uses target capture for in vitro qualitative detection and differentiation of rRNA from C. trachomatis and N. gonorrhoeae in endocervical and male urethral swab specimens and in urine specimens. The assay uses target capture (TC), Transcription-Mediated Amplification (TMA) and Dual Kinetic Assay (DKA) (Gen-Probe, Inc., San Diego, Calif.).
However, in view of the myriad of different pathological agents that mediate disease conditions, a need indeed exists for materials and methods to collect an accurate clinical sample, e.g. a “snapshot,” representative of a certain gynecological microbiological environment, for example, and maintain the detectability of the diversity of pathological agents in a single gynecological sample. Methods are particularly needed for receiving and handling a plurality of single gynecological swab clinical samples, each having identity and test requisition information associated therewith, wherein the test requisition information indicates a test for at least one causative agent from a plurality of listed agents, and managing information associated therewith for reporting a sum of diagnostic results for each sample.